Measuring tool using suture and suture anchor

ABSTRACT

Measuring tool, surgical constructs, and methods for measuring distances between two or more locations. A measuring device allows for simple and accurate intraoperative length measurements to be made. A measuring device has a distal end that can hold a flexible strand in a hole, eyelet, claw, or other suitable means. A shaft of the device has calibration markings on it, with the zero point at the end opposite the distal tip.

CROSS REFERENCE TO RELATED APPLICATION

This is a divisional of U.S. patent application Ser. No. 14/807,469,filed Jul. 23, 2015, the entire disclosure of which is incorporatedherein by reference in its entirety.

BACKGROUND

The present disclosure relates to surgical devices tissue repairs and,in particular, to devices and measuring tools.

SUMMARY

Devices, tools, and methods for measuring distances between two or morepoint s or locations during surgical procedures are disclosed.

A measuring device allows for simple and accurate intraoperative lengthmeasurements to be made. A measuring device has a distal end that canhold a flexible strand in a hole, eyelet, claw, or other suitable means.A shaft of the device has calibration markings on it, with a zero pointat an end opposite the distal tip.

A measuring device is provided with a flexible strand from a fixationdevice to span a distance either curved or straight, and determineaccurate measurement. As the flexible strand is secured to the fixationdevice, it makes it a secure “zero” point to measure from.

A calibrated instrument holds a flexible strand (suture) at a distal tipof the instrument. A flexible strand is zeroed out with a marker or by asimilar method. A calibrated instrument is then moved to a desiredlocation and a flexible strand will slide along the instrument and themeasurement can be determined. An arc length or curvature of a portionof a bone with a curvature may be determined.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a measuring tool according to anexemplary embodiment.

FIG. 2 illustrates a schematic view of a distance between two exemplarypoints (corresponding to two fixation devices) to be measured with themeasuring tool of FIG. 1.

FIGS. 3 and 4 illustrate an exemplary method of intraoperative lengthmeasurement with the measuring tool of FIG. 1.

DETAILED DESCRIPTION

Surgical constructs, systems, measuring tools, and techniques formeasuring distances between two or more locations during surgicalprocedures and soft tissue repair and fixation, such as fixation of softtissue (ligament, tendon, graft, etc.) to bone are disclosed.

A measuring device allows for simple and accurate intraoperative lengthmeasurements to be made. A measuring device has a distal end that canhold a flexible strand in a hole, eyelet, claw, or other suitable means.A shaft of the device has calibration markings on it, with the zeropoint at the end opposite the distal tip.

A measuring device is provided with a flexible strand from a fixationdevice to span a distance either curved or straight, and determineaccurate measurement. As the flexible strand is secured to the fixationdevice, it makes it a secure “zero” point to measure from.

A calibrated instrument holds a flexible strand (suture) at a distal tipof a shaft instrument. The flexible strand is zeroed out with a markeror by a similar method or with similar device. The calibrated instrumentis then moved to a desired location on a bone surface, and the flexiblestrand will slide along the instrument and the measurement can bedetermined. A distance between two points, or an arc length or curvatureof the bone surface of the portion of the bone spanned by the instrumentmay then be determined, for example, by reading graduated markings orcalibrations on the shaft of the instrument, or by counting the numberof graduated markings.

A measurement tool or arthroscopic measuring device may be utilized inan operation where an anchor with two suture ends extending therefromhas already been implanted. To make a measurement, a suture end ispassed through the distal tip of the tool, and the distal tip is pusheddown until it contacts the suture anchor. The suture end or ends arethen marked in any suitable manner, or alternatively one suture end isrigidly clamped in place while the other suture end is passed throughthe instrument. The instrument is then moved to the desired locationover a bone surface, and the suture end or ends will slide down thecalibrations. The mark on the suture end will identify the distancetraveled by the instrument. An arc length or curvature of the bonesurface of the portion of the bone spanned by the instrument may then bedetermined, for example, by reading graduated markings or calibrationson the shaft of the instrument, or by counting the number of graduatedmarkings.

A surgical construct includes a fixation device (a suture anchor) with aflexible strand (a suture) attached to the fixation device and connectedto a calibrated instrument (measuring tool). The fixation device isinserted into bone at a first location. To make a measurement, one endof the flexible strand is passed through a closed eyelet at the distaltip of the calibrated instrument (measuring tool), and the distal tip ispushed down until the distal end of the calibrated instrument contactsthe fixation device (suture anchor). The flexible strand is zeroed outwith a marker or by a similar method or with similar device, i.e., theflexible strand is marked to indicate the zero point of the calibratedinstrument. The calibrated instrument is then moved to a desired, secondlocation on the bone surface. The flexible strand slides along the shaftof the calibrated instrument and the measurement/distance can bedetermined. A measured distance may indicate a location of a secondfixation device (a second suture anchor). A second fixation device maysecure tissue to bone, for example, soft tissue to bone. A secondfixation device may also secure one or two ends of the flexible strandattached to the fixation device.

In an illustrative embodiment, a surgical construct comprises a fixationdevice with a body, a proximal end, a distal end, a longitudinal axis,and a flexible strand extending from the fixation device. A flexiblestrand may be securely attached to, and extend therefrom, the fixationdevice. In an embodiment, the flexible strand is passed through anopening at a most distal end of a calibrating instrument or device(measuring tool). A calibrating instrument is advanced over an outersurface of a substantially non-straight structure, for example, a bonycurved structure, so that the flexible strand from the fixation devicespans a distance either curved or straight, and determine accuratemeasurement. As the flexible strand is secured to the fixation device,it makes it a secure “zero” point to measure from.

Methods of length measurements and soft tissue repairs which allowprecise placement and location of the tissue with respect to the boneare also disclosed. An exemplary method comprises inter alia: (i)inserting a fixation device (for example, an anchor) with an attachedflexible strand (for example, suture or filament) into tissue at a firstlocation; (ii) passing at least one limb of the flexible strand throughan eyelet or opening of a calibrated shaft of a measuring instrument;(iii) moving the calibrated shaft with the flexible strand to a secondlocation; and (iv) measuring a distance between first and secondlocations by determining a distance traveled by the at least one limbrelative to the calibrated shaft. A second location may be indicative ofplacement of another fixation device. The another fixation device maysecure the flexible strand. A second location may indicate an end of anarc or curvature of a portion of a bone with curvature such as, forexample, glenoid, tuberosity, or condyle. The flexible strand may securesoft tissue to bone.

In another embodiment, a method of tissue repair comprises: (i) securinga surgical construct into bone, the surgical construct comprising afixation device (for example, a suture anchor) and a flexible strandsecured to the fixation device; (ii) passing first and second limbs ofthe flexible strand through a closed eyelet at a distal end of acalibrated measuring instrument; and (iii) using the first and secondlimbs to measure a distance between two locations over a surface of thebone. In an embodiment, the first and second limbs slide along a shaftof the instrument and the measurement can be determined by reading thecalibrations or graduated markings on the shaft of the instrument.Distance x may indicate a distance between the fixation device andanother fixation device. Distance x may indicate an arc length of aportion of the bone with a curvature.

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1-4 illustrate exemplary device 50(measuring tool 50 or arthroscopic measuring device 50) of surgicalconstruct 100 for intraoperatively measuring distance “x” between twooperative locations, for example, between locations of two fixationdevices secured into body tissue such as bone. Surgical construct 100may also be employed to determine an arc length or curvature of aportion of a bone with a curvature, or to determine the comet placementof two or more fixation devices over a portion of bone with or withoutcurvature.

Surgical construct 100 is formed of device 50 (measuring tool ormeasuring device 50) and fixation device 10 provided with flexiblestrand or flexible material 30 (suture 30) secured to (attached to) thefixation device 10. In an exemplary embodiment, the flexible strand 30is a suture strand 30 and the fixation device 10 is a suture anchor 10.Flexible strand 30 operatively extends between the fixation device 10and the device 50.

Device 50 (measuring tool or measuring device 50) includes a shaft 52with a proximal end 51 and a distal end 53. A closed eyelet 55 (opening,hole, claws or similar structure 55) is provided at distal end 53.Closed eyelet 55 is sized to allow easy passage of one or more limbs offlexible strand 30 to pass therethrough and to aid in methods ofassessing and determining a length or distance between two or morepoints/locations on a tissue surface (for example, an arc length of asurface of a portion of bone with a curvature). A plurality of graduatedmarkings 57 (set of gradations 57) are provided on shaft 52 of themeasuring tool or device 50, starting from the proximal end 51. In anexemplary embodiment, graduated markings 57 extend from a “zero” pointto a “60 mm” point, as shown in FIG. 1, with zero point coinciding witha most proximal end of shaft 52.

In an exemplary embodiment, fixation device 10 is in the form of asuture anchor 10 (for example, a knotless suture anchor 10) having ananchor body 11 provided with a longitudinal axis 11 a, a proximal end13, and a distal end 12. A plurality of ribs, ridges, or threads 15 mayextend circumferentially around at least a part of anchor body 11. Acannulation may be provided within anchor body 11 and extends along thebody 11, to allow one or more flexible strands 30 to pass therethrough.Flexible strand 30 may be a suture strand or any suture-like materialknown in the art that could pass through or around tissue and could befurther secured to another fixation device. Flexible strand 30 may besecurely attached to fixation device 10 by known methods in the art suchas insert molding, for example.

Anchor 10 may be a screw-in anchor or a push-in style anchor. Anchor 10may be forming of metals, metal alloys, biocompatible plastics such asPEEK, or a bioabsorbable material such as PLLA material. A socket may beprovided at the proximal end 13 of the anchor 10, to securely engage atip of a driver. Anchor 10 may be made of one or more pieces, or may beprovided as an integrated device.

Reference is now made to FIG. 2 which illustrates a length or distance“x” between two fixation devices, for example, between first fixationdevice 10 and second fixation device 110, to be measured with device 50of surgical construct 100. Second fixation device 110 may have beenalready provided within tissue (for example, bone 90) and thus distance“x” indicates the distance between the two inserted fixation devices 10,110. Alternatively, distance “x” may indicate the correctplacement/location of where the second fixation device 110 will beinserted/affixed to bone.

FIG. 2 depicts a first fixation device 10 (suture anchor 10) placed intobone 90 at a distance “x” away from a second fixation device 110 (asecond anchor 110) that is needed, i.e., that needs to be secured tobone 90, or that has been already secured into bone. The instrument 50uses the suture 30 from the first anchor 10 to measure distance “x”. Theinstrument 50 can hold the suture 30 at the distal tip (with a hole 55or claws) and has calibrations or graduated markings 57 on it.

A method of measuring a distance over straight or curved bone surfaceswith device 50 of surgical construct 100 is detailed below withreference to FIGS. 3 and 4.

FIG. 3: fixation device 10 (suture anchor 10) is secured into bone 90 ata first location A on outer bone surface 91. The sutures 30 from thefixation device 10 (suture anchor 10) are fed through the opening 55 ofthe distal end 53 of device 50, and the distal end 53 is pushed down thesutures 30 until the distal end 53 of the instrument 50 contacts sutureanchor 10. The sutures 30 are then marked M at the zero point of theinstrument 50 (i.e., at a most proximal end of the instrument 50 whichindicates 0 mm marking). Alternatively, one suture limb can be rigidlyfixed with a clamp. The other single limb can be used through theinstrument 50. Instead of marking with a marker, the sutures 30 could beheld in a type of clamp at the zero point on the instrument and theclamp can slide down the shaft.

FIG. 4: The instrument 50 is then moved to the desired location, i.e., asecond location B on outer surface 91 of bone 90. Sutures 30 will slidedown the shaft 52 and calibrations 57 to position M1. The mark M on thesuture will identify the distance “x” traveled by the instrument 50. Inan exemplary embodiment, position M1 corresponds to markings 60 mm, thusdistance x=60 mm.

The surgical constructs and systems detailed above are used inconjunction with any tissue repairs such as attachment of soft tissue tobone which require determining distances over straight or curved bonesurfaces, and attach soft tissue to bone with various fixation devicessuch as screws, anchors, and implants, among many others.

A method of determining a distance between two different points orlocations on a bone surface comprises: (i) securing a fixation device 10(for example, a suture anchor 10) into bone 90, the fixation device 10having at least a flexible strand 30 secured thereto; (ii) passing theflexible strand 30 through a closed opening 55 of a measuring tool 50;and (iii) using the flexible strand 30 from the fixation device 10 tomeasure a distance x between the fixation device 10 and another locationB on the bone 90. In an embodiment, the measuring tool 50 is providedwith a plurality of graduated markings or calibrations 57. By moving theinstrument 50 from a first location A (coinciding with the locationwhere the first fixation device 10 has been installed into bone 90) tosecond location B on the bone 90, the flexible strand 30 will slide downa shaft 52 of the measuring tool 50 and indicate the distance x traveledby the measuring tool 50.

An exemplary application of the measuring tool 50 is shoulderarthroscopy, which requires measuring of arcs over the glenoid orshoulder tuberosity. As the arcs are non-straight lines, measuring thesedistances is facilitated by the measuring instrument, surgicalconstruct, and methods of the present disclosure, especially when asurgeon needs to come from non-right angles with variable angles ofmeasurements.

Device 50 and surgical construct 100 detailed above use asuture/flexible strand attached to a fixation device as a guide over thearc or distance of the bone structure to be measured. The distance onthe calibrated device 50 may be measured extra-articularly, so a surgeonwill not need to read the markings/numbers inside (i.e.,intra-articularly). The measurement is predictable and accurate asinstrument 50 and surgical construct 100 provide a steady method with afixed location (the suture secured into suture anchor, providing a“zero” point to measure from).

Fixation devices 10, 110 may be any of swivel and/or screw-in sutureanchors and/or push-in suture anchors (such as an Arthrex SwiveLock®anchor, disclosed in U.S. Pat. No. 9,005,246 or a PushLock® anchor, asdisclosed in U.S. Pat. No. 7,329,272). Fixation devices 10, 110 may bealso any anchors, implants or screws (such as interference screws ortenodesis screws) or any fixation element that allowsattachment/fixation of the limbs of flexible strand 30 to bone. Thefixation devices/implants may have various sizes (various diametersand/or lengths) and may be formed of biocompatible materials such asPEEK, biocomposite materials, metals and/or metal alloys, or combinationof such materials, among others. Flexible strand 30 may further beprovided around or through tissue to attached to another tissue, forexample, through or around soft tissue to be secured/attached to bone.

Flexible strand 30 may be a suture strand or any suture-like materialknown in the art that could pass through tissue and eyelet 55 of themeasuring tool 50. May include a high-strength suture, such as anultrahigh molecular weight polyethylene (UHMWPE) suture. High strengthsuture may be a FiberWire® suture (Arthrex). FiberWire® suture is formedof an advanced, high-strength fiber material, namely ultrahigh molecularweight polyethylene (UHMWPE), sold under the tradenames Spectra®(Honeywell International Inc., Colonial Heights, Va.) and Dyneema® (DSMN.V., Heerlen, the Netherlands), braided with at least one other fiber,natural or synthetic, to form lengths of suture material. Flexiblestrand 30 may be also formed of a stiff material, or combination ofstiff and flexible materials, depending on the intended application. Thestrand may be also coated and/or provided in different colors.

What is claimed is:
 1. A method of measuring distance between two ormore locations on body tissue during surgery, comprising: securing afixation device in the body tissue, the fixation device comprising abody and a flexible strand attached to the body; passing at least onelimb of the flexible strand through a closed eyelet of a distal end of ameasuring tool; using the at least one limb of the flexible strand fromthe fixation device to measure a distance between the fixation deviceand another location on the body tissue, with the measuring tool;advancing the distal end of the measuring tool down the at least onelimb of the flexible strand, so that the distal end of the measuringtool contacts the fixation device; marking the at least one limb of theflexible strand at a most proximal end of the measuring tool; moving themeasuring tool to the another location on the bone, so that the at leastone limb of the flexible strand slides down the measuring tool; anddetermining a calibration or gradation on a shaft of the measuring toolthat corresponds to the distance between the fixation device and theanother location on the bone.
 2. The method of claim 1, wherein the bodytissue is bone.
 3. The method of claim 1, wherein the body tissue isshoulder under arthroscopy, and the fixation device is a screw-in or apush-in anchor.
 4. The method of claim 1, wherein the surgery isarthroscopic surgery.
 5. The method of claim 1, wherein the flexiblestrand is suture and the fixation device is a knotless suture anchor. 6.The method of claim 1, further comprising securing the at least one limbof the flexible strand with additional fixation devices.
 7. The methodof claim 6, wherein the additional fixation devices are knotlessanchors.